Self Nano-Emulsifying Drug Delivery System (SNEDDS) for Cyproterone Acetate: Formulation, characterization and pharmacokinetic evaluation

Abstract

The study aimed to develop a SNEDDS to enhance the solubility and bioavailability of cyproterone acetate (CPA). Various oils, surfactants, and co-surfactants were evaluated for compatibility, with the optimized formulation characterized using Zeta-sizer, FTIR, DSC, and TGA. The SNEDDS was used to study the release and penetration of CPA for two and twenty-four hours, respectively. The lipolysis test, RBC lysis, and pharmacokinetics were among the study subjects. Particle size of 125 ± 5 nm, polydispersity index (PDI) of 0.15 ± 0.01, and zeta potential of −25 ± 2 mV were observed in the SCT3 formulation. The thermal stability and chemical compatibility were demonstrated by FTIR, DSC, and TGA. Ninety percent of the CPA released from SCT3 and 75 % of it permeated. SCT3 digestion produced a significant amount of CPA and minimal RBC lysis in the lipolysis test. The Caco-2 cell viability was 87 % according to the SCT3 SNEDDS. In comparison to the reference formulation, the pharmacokinetics of SCT3 demonstrated enhanced values of C_max, T_max, half-life, MRT, AUC, and AUMC. According to our research, the SNEDDS demonstrating high solubility and bioavailability in pharmacokinetic evaluations.